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The Opticage® Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior, transforaminal or lateral approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. Candidates for surgery should be skeletally mature and have had six months of conservative treatments. may have had primary or secondary surgery, but no previous fusion at the involved levels. The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

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I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or any study that proves the device meets specific acceptance criteria. This document is a 510(k) clearance letter from the FDA for the Opticage® Expandable Interbody Fusion Device, which primarily states that the device is substantially equivalent to legally marketed predicate devices.

The document includes:

• The device name and regulation information.
• Indications for Use.
• A statement that the device is cleared for marketing subject to general controls provisions of the Act.

It does not contain details about:

1. Acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithmic performance studies.
7. Type of ground truth used in studies.
8. Training set sample size or how its ground truth was established.

This type of information is typically found in a summary of safety and effectiveness, clinical study reports, or performance testing sections, which are not part of this specific FDA clearance letter.

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The Opticage™ Expandable Interbody Fusion Device is a lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Expandable Interbody Fusion Device can be implanted via posterior, transforaminal, or lateral approach.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.

The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).

The Opticage™ Expandable Interbody Fusion Devices, Model Series 9070 are designed for lumbar intervertebral body fusion via posterior, transforaminal or lateral approach. The devices are fabricated from titanium alloy (Ti-6AI-4V) as per ASTM Fl36. Each device consists of an upper and lower titanium plate, two titanium wedges and a central shaft. The two titanium wedges are connected by the central shaft. The shaft can be rotated to move the wedges toward the center of the device thereby increasing the distance (i.e. height) between the upper and lower titanium plates. Alternatively, the shaft can be rotated in the opposite direction to move the wedges away from the center of the device causing the distance (i.e. height) between the upper and lower plates to decrease. In this manner, the height of the construct can be continuously adjusted. The devices are available in a several footprint sizes. The top and bottom of the devices are fenestrated and each contain windows to enhance bony in growth. A cavity internal to each device is intended to hold autogenous bone graft.

The Opticage Expandable Interbody Fusion Devices in Model Series 9070 are provided in both sterile and non-sterile versions.

This document (K140716) is a 510(k) premarket notification for a medical device called the Opticage™ Expandable Interbody Fusion Device. As such, it focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing acceptance criteria and proving the device meets those criteria through a primary clinical study.

The FDA 510(k) pathway does not typically require clinical trials in the same way a PMA (Premarket Approval) does, especially for Class II devices like this one. Instead, it relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of typical AI/diagnostic device performance metrics (like sensitivity, specificity, etc., with associated sample sizes, ground truths, and reader studies) is not directly applicable or present in this 510(k) submission.

However, I can extract the information related to the performance data provided to support the claim of substantial equivalence. This "performance data" serves the purpose of demonstrating that the new device functions similarly and is as safe as the predicate devices.

Here's a breakdown based on the provided document, addressing the closest analogues to your request:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there aren't "acceptance criteria" in the traditional sense of a diagnostic performance study (e.g., minimum sensitivity). Instead, the performance claims are based on meeting established standards for intervertebral body fusion devices, and demonstrating comparable performance to predicate devices.

• Static compression
• Dynamic compression
• Static compression shear
• Dynamic compression shear
• Static torsional
• Dynamic torsional |
  | ASTM F2267 | Subsidence testing completed for Opticage™ Model Series 9070. |
  | ISO 17853 | Evaluation of wear debris/particulates completed for Opticage™ Model Series 9070. |
  | ASTM F1877 | Evaluation of wear debris/particulates completed for Opticage™ Model Series 9070. |
  | Not explicitly listed, but implied | Expulsion testing completed for Opticage™ Model Series 9070. |
  | Not explicitly listed, but implied | Finite Element Analysis (FEA) conducted to confirm worst-case performance configuration. |
  | Overall Comparison to Predicates | "Test performance data demonstrated substantial equivalence to the predicate devices." (Specifically Caliber® Spacer (K123231), L-Varlock Lumbar Cages (K080537), Caliber™ Spacer (K102293), and referenced Opticage models (K113527, K132479, K133583)). The device has similar size, shape, and material composition (Ti-6AL-4V) to predicates, with similar operational characteristics. |

2. Sample Size Used for the Test Set and Data Provenance

This document describes mechanical and material testing, not clinical or diagnostic performance testing with human subjects. Therefore, the concept of a "test set" in terms clinical data or patient images (as would be relevant for an AI device) does not apply. The "samples" would be the physical devices or components tested according to the ASTM and ISO standards. The document does not specify the number of devices or components tested, nor their manufacturing origin (country). This type of testing is generally performed in a lab setting by the manufacturer or contracted labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable.

• For mechanical and material testing, ground truth is established by the physical properties and performance characteristics of the materials and device components as measured against established engineering standards (ASTM, ISO). There are no "experts" establishing a "ground truth" in the clinical sense.

4. Adjudication Method for the Test Set

Not applicable.

• There is no "adjudication" in the context of mechanical device testing; the results are typically quantitative and objective measurements against predefined criteria in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not applicable.

• This is a mechanical implant device, not a diagnostic imaging device or an AI algorithm intended to assist human readers. Therefore, an MRMC study is outside the scope of this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable.

• This device is a physical implant for spinal fusion, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established engineering and material science standards (e.g., ASTM F2077-03, ASTM F2267, ISO 17853, ASTM F1877) that dictate acceptable performance ranges for intervertebral body fusion devices. The device's performance against these standards, and its similarity to predicate devices, forms the basis for demonstrating safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable.

• There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

• No training set exists for this type of device submission.

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